Methodology:
This is a retrospective observational study conducted at AUBMC. We included adult patients (≥ 18 years) with a positive test result for SARS-CoV-2 polymerase-chain-reaction or rapid antigen test who received IV Sotrovimab either in the Emergency Department (ED) upon presentation or during hospitalization for hospital-acquired COVID-19 from November 2021 through March 2022.
Due to the limited supply, Sotrovimab was prioritized for immunocompromised patients who were unvaccinated against COVID-19 or those who were fully or partially vaccinated but were not expected to mount an adequate immune response to the vaccine. We developed criteria for the use of Sotrovimab based on the NIH guidelines. As such, only patients with a high risk of disease progression were eligible to receive Sotrovimab after the approval of two infectious disease attending physicians. Major risk factors for clinical progression included: age (≥ 65 years), obesity (BMI ≥ 30), immune suppression, cardiovascular disease (including congenital heart disease) or hypertension, and chronic lung diseases (i.e., Chronic Obstructive Pulmonary Disease (COPD), moderate to severe asthma, interstitial lung disease, cystic fibrosis, and pulmonary hypertension). Other risk factors contributing to disease progression were CKD, pregnancy, sickle cell disease, and neurodevelopmental disorders.
The collected data included patient demographics such as COVID-19 vaccination status, clinical characteristics (e.g., duration of symptoms, risk factors for disease progression), history of use of other monoclonal antibodies and concurrent immunosuppressive medications, data related to the use of Sotrovimab (e.g., dosing regimen, administration, drug interactions), and outcomes. This study was approved by the Institutional Review Board of the AUBMC. The requirement for informed consent was waived because of the retrospective nature of the study. Patient anonymity and privacy were respected by deleting all subjects’ identifiers such as medical record number and full name from the data collection sheet and each subject received a unique identifier number for data collection purposes.
Primary outcomes were hospitalization, deterioration after 24 hours, and death due to any cause at day 60 after the Sotrovimab infusion. Hospitalized patients were further classified into those who were already admitted to the hospital for a reason other than COVID-19 and those who were hospitalized due to COVID-19. Patient deterioration was defined as oxygen saturation SpO2 ≤ 94% on room air and/or the need for supplemental oxygen. Secondary outcomes were progression to critical illness and adverse events. Critical illness was defined as patients on mechanical ventilation and/or extracorporeal mechanical oxygenation (ECMO). It also included -end-organ dysfunction as seen in sepsis/septic shock and acute respiratory distress syndrome (ARDS).
The appropriateness of Sotrovimab use was assessed as well, since the drug was recently added to the institution’s formulary. The use of Sotrovimab was restricted to patients that met the above criteria. Each prescription order was reviewed by the pharmacist to verify the patients’ eligibility in addition to securing the required approval of two infectious diseases (ID) physicians. The appropriateness of use was assessed by collecting data related to indication, dosing regimen, administration route, rate of infusion, and contraindications. Drug-drug interactions were screened, and any adverse drug events were reported.
Descriptive statistics were used. Continuous variables were expressed by mean values and standard deviations (SD). Categorical variables were expressed as frequencies and percentages. Data were analyzed using Statistical Package for Social Sciences (SPSS) v.25.